Changes in EU regulation of the pharmaceutical area

Abstract

The subject matter for this thesis is the pharmaceutical area from 2013-2023, how it has developed, what characterises it, how COVID-19 affected the regulatory framework, and the cooperation between member states and the European Union. Prior studies have shown that the EU has showed great interest and initiative on the pharmaceutical area with increased integration since the 2000s. Data was gathered through document review and expert interviews was conducted to gain knowledge on the pharmaceutical area’s regulatory framework, but also to gain insight into the key aspects as well as regulations according to those experts. The findings show that EU regulation on the pharmaceutical area has increased, however, the COVID-19 pandemic has hitherto not been as a significant force for further integration as one would have expected. DG HERA was created by the Commission to respond and prepare for future health emergencies, the procurement mechanism was expanded upon, among other initiatives. Reshoring production capacity for pharmaceutical and medical products back to Europe, however, was not driven by the pandemic, but the pandemic made it a highly salient issue.